drugset / Trial / NCT01336751
Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment
RandomizedParallel-groupOpen-labelTreatment
Summary
Study Primary Objectives: To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin. Study Secondary Objectives : To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro: * Incidence of hypoglycemia * Change in weight * Change in serum lipid profile * Percentage of subjects achieving A1C levels ≤7%
Timeline
- Start
- 2001-07
- Primary completion
- 2002-12
- Completion
- 2002-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |